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This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine.
The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed).
In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-334543 + gemcitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-334543, EGFR/ErbB2 inhibitor; oral | Drug | multiple dose, escalating |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine. | Part 1 | |
| Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. | Part 1 | |
| Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite. | Part 1 | |
| Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks. | Part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response. | Part 1 | |
| Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. |
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Key Inclusion Criteria (Part 1):
Key Exclusion Criteria (Part 1):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Oncology/Hematology | Phoenix | Arizona | 85258 | United States | ||
| Premiere Oncology |
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| Gemcitabine, nucleoside analogue; intravenous |
| Drug |
multiple dose, single schedule |
|
| Part 2 |
| Santa Monica |
| California |
| 90404-2111 |
| United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Partners, Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Partners, Dana Farber | Boston | Massachusetts | 02115 | United States |
| Sarah Cannon Research Center | Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000595244 | ARRY-334543 |
| D000093542 | Gemcitabine |
| D009705 | Nucleosides |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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